MAUDE Adverse Event Report: MAILLEFER INSTRUMENTS HOLDING SARL PROTAPER UNIVERSAL; 25MM; FILE, PULP CANAL, ENDODONTIC

Catalog Number UNK MAILLEFER

Device Problems Break (1069); Difficult to Remove (1528)

Patient Problems Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

As a result of this malfunction, the potential for surgical intervention exists to preclude permanent damage to a body structure or permanent impairment of a body function as evidenced by previous reported events with similar files.This event, therefore, is reportable per 21cfr part 803.The device was not returned for evaluation.However, the lot number was provided and retained-product testing and/or dhr review are planned.The results will be submitted as they become available.

Event Description

In this event it has been reported that protaper universal file 25mm-s1 was broken during use.The broken part can not be retrieved and filled in the canal.There is no patient injury occurred.

Manufacturer Narrative

Involved products that broke during use were not returned and cannot be analyzed.Moreover, no unused file is available for evaluation.The provided batch number (batch #14772997) has no corresponding in our system and is likely erroneous (8 digits; standard maillefer batches only have 7 digits).The right batch number is unknown, dhr cannot be reviewed.Root causes are not identified.We will track this kind of event and monitor the trend.

• Brand Name: PROTAPER UNIVERSAL; 25MM
• Type of Device: FILE, PULP CANAL, ENDODONTIC
• Manufacturer (Section D): MAILLEFER INSTRUMENTS HOLDING SARL; ch. du verger 3; ballaigues vaud CH-13 38; SZ CH-1338
• Manufacturer (Section G): MAILLEFER INSTRUMENTS HOLDING SARL; ch. du verger 3; ballaigues vaud CH-13 38; SZ CH-1338
• Manufacturer Contact: hannah seevaratnam ; 221 west philadelphia st.; york, PA 17401 ; 7178457511
• MDR Report Key: 13112466
• MDR Text Key: 285327330
• Report Number: 8031010-2021-00400
• Device Sequence Number: 1
• Product Code: EKS
• Combination Product (y/n): N
• Reporter Country Code: CH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date: 03/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: UNK MAILLEFER
• Device Lot Number: 14772997
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 12/16/2021
• Date Manufacturer Received: 12/16/2021
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/14/2019
• Type of Device Usage: A
• Patient Sequence Number: 1
• Patient Age: 19 YR
• Patient Sex: Male